Sentinel Node Biopsy Following NeoAdjuvant Chemotherapy in Biopsy Proven Node Positive Breast Cancer

Not Applicable

Completed

• Conditions: Invasive Breast Cancer; Breast Cancer
• Interventions: Procedure: Sentinel Lymph Node Biopsy

• Registration Number: NCT00909441
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary

Title of Study: Sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.

Objectives of the study:

Primary objective

1. Evaluate the accuracy of sentinel node biopsy in breast cancer patients presenting with positive nodal disease, proven by ultrasound guided fine needle aspiration, following neoadjuvant chemotherapy.

Secondary objectives

1. Evaluate the technical success of sentinel node biopsy following neoadjuvant chemotherapy.

2. Evaluate the accuracy of clinical examination and ultrasound examination of the axilla in identifying the presence of residual disease in the axilla following neoadjuvant chemotherapy in biopsy proven node positive breast cancer patients.

Number of patients:

N = 300

Population:

Patients with unresected breast cancer that are eligible for neoadjuvant chemotherapy that present with biopsy proven positive axillary nodes.

Study duration:

From February 2009 to February 2012 - 3 years

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-05-25
• Study First Submitted QC: 2009-05-27
• Study First Posted: 2009-05-28
• Status Verified: 2011-06
• Primary Completion: 2012-02
• Study Completion: 2012-12
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 153

Inclusion Criteria

Not provided

Exclusion Criteria

• Patients with inflammatory breast cancer.
• Patient with stage IIIB, IIIC or IV breast cancer (T4 and N3) Patients with clinical N3 disease are excluded.
• Patients that have had previous axillary dissection or an axillary sentinel node biopsy; (patients that have had excisional biopsy or ipsilateral tumorectomy are eligible).
• Patients that have had previous radiotherapy to the axillary nodes
• Patients that have had mammary reduction
• Patients that are medically unfit to receive chemotherapy, as evaluated by the treating physician.
• If the injection of blue dye is planned, patients with hypersensitivity or allergy to isosulfan blue, Patent blue or methylene blue or radiocolloid dye are ineligible.
• Patients who are pregnant or breast feeding .
• Psychiatric or addictive disorders or other conditions that preclude the patient from meeting the study requirements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SNB + ALND	Sentinel Lymph Node Biopsy	Intervention: Sentinel Lymph Node Biopsy followed by Axillary Node Dissection.

Primary Outcome Measures

Name	Time	Method
The false negative rate of sentinel node biopsy following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.	4-7 months

Secondary Outcome Measures

Name	Time	Method
Evaluate the accuracy of clinical evaluation and ultrasound examination in determining the presence of residual disease following neoadjuvant chemotherapy in biopsy proven node positive breast cancer.	3-6 months
Evaluate the technical success rate of sentinel node biopsy following neoadjuvant chemotherapy	4-7 months

Trial Locations

Locations (1)

Centre de recherche du Centre hospitalier de l'Université de Montréal; 🇨🇦 Montréal, Quebec, Canada